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CDISC Technology. HITSP, 15 th October 2008 Dave Iberson-Hurst CDISC VP Technical Strategy. The Request. Current interchange formats (strengths and weaknesses)

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CDISC Technology

HITSP, 15th October 2008

Dave Iberson-HurstCDISC VP Technical Strategy


The Request

  • Current interchange formats (strengths and weaknesses)

    • Consider all healthcare information interchange architectures such as messaging, structured documents, health records and service oriented architectures

    • Consider transport and security

  • Relationship among your interchange formats, if multiple

  • XML now or in future plans

  • “Style Guide” of how information transformed into interchange format

  • Available tools, e.g., mappings or transforms

  • Supported architectures


Overview


CDISC

The mission of CDISC is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare.


Technical Vision

  • Documented in Technical Road Map

    • http://www.cdisc.org/about/downloads/CDISC_Road_Map_Spring2008.pdf

  • Next version released Q4 2008/Q1 2009

  • Will encompass

    • more integrated approach

    • improved process


* Specification referenced via FDA Final Guidance


The Foundation Stone

Design

Execute

Analyse & Submit

Protocol

CDASH

LAB

SDTM(SEND)

ADaM


The Foundation Stone

  • Integrated standards

  • Protocol to Submission

  • The foundation stone

  • Then …

    • We can grow standards into other areas

    • The basis for the evolution of the CDISC products


Key Principles


Aligned With and By BRIDG

Biomedical Research Integrated Domain Model (BRIDG)

Protocol

CDASH

LAB

SDTM

(SEND)

ADaM


Same Concept, Same Meaning

Biomedical Research Integrated Domain Model (BRIDG)

Protocol

CDASH

LAB

SDTM(SEND)

ADaM


BRIDG - What is it?

The BRIDG model is an instance of a Domain Analysis Model (DAM). As such, it depicts a shared representation of the dynamic and static semantics of a particular domain-of-interest.


The Revised, 2-layered (2-views) BRIDG Model

Consistent levels of abstraction and explicitness in multiple sub-domain ‘Requirements Models’

Understandable to Domain Experts

Sub-Domain 1

Sub-Domain 2

Sub-Domain 3

Sub-Domain 4

Sub-Domain 5

Consistent levels of standards-compliance and explicitness in a single ‘Analysis Model’

Unambiguously mappable to HL7 Reference Implementation Model

Slide courtesy of Charlie Mead & John Speakman, NCI


Use of BRIDG

ApplicationDevelopment

Message Development

Data ExchangeStandards


Alignment

ApplicationDevelopment

Message Development

Data ExchangeStandards


Quarter 2, 2009

Biomedical Research Integrated Domain Model (BRIDG)

Protocol

CDASH

LAB

SDTM

(SEND)


By The End of 2009

Biomedical Research Integrated Domain Model (BRIDG)

Protocol

CDASH

LAB

SDTM

(SEND)

ADaM


Separation of Content and Transport

  • Key Items

    • BRIDG (broader audience via ISO)

    • Terminology

    • Consistently applied across all standards

Protocol

CDASH

LAB

SDTM (SEND)

ADaM

Transport


Transport

BRIDG

Protocol

CDASH

LAB

SDTM SEND)

ADaM

ODM & Extensions

Define.xml

SAS XPT


Transport

BRIDG

Protocol

CDASH

LAB

SDTM(SEND)

ADaM

ODM & Extensions

HL7 V3


Use of XML

  • CDISC

    • Operational Data Model

    • Laboratory Model

  • HL7

    • HL7 Messages (FDA regulatory submission)

    • CDA being investigated


Integrated with healthcare

Medical Research

Protocol

CDASH

LAB

SDTM

(SEND)

ADaM

Healthcare


Integrated with Healthcare

  • Working with Integrating the Healthcare Enterprise (IHE)

    • HIMMS 2007, 2008 and 2009

    • Retrieve Form for Data Capture (RFD)

    • Further (content) profiles being developed

      • CDASH

      • Protocol

  • RFD reached level of maturity

  • Ready for the next leap


Integrated with Healthcare

  • Working with Integrating the Healthcare Enterprise (IHE)

    • HIMMS 2007, 2008 and 2009

    • Retrieve Form for Data Capture (RFD)

    • Further (content) profiles being developed

      • CDASH

      • Protocol

  • RFD reached level of maturity

  • Ready for the next leap

STOP PRESS!

RFD Goes Live. First two subjects enrolled in a live study 15th December 2008


FDA PDUFA IV IT Plan


Target Clinical Data Flow

Site

Sponsor

CDISC Content and Interchange

Interchange:

HL7 output file

CDISC Content

CDASH

CDASH

ODM

Trial Design

Sponsor

Data

Warehouse

(ODM)

Data Checker

and Loader

FDA Reviewers

Review

Tools

Janus

FDA/NCI

Analytical Data

Warehouse

Site Data

Archive

(ODM)

MedWatch AE Reports (ICSR)


PDUFA IV IT Plan

  • Lists key CDISC projects

    • SDTM

    • CDISC HL7

    • BRIDG

    • SEND

    • CDASH

    • ADaM

  • Links

    • http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-N-0352-bkg.pdf

    • http://www.accessdata.fda.gov/scripts/oc/ohrms/dailylist.cfm?yr=2008&mn=6&dy=30


Summary


Summary

  • Complete the “Foundation Stone” of content

  • Consistency across the CDISC standards

  • Stability of the CDISC standards

  • Evolution of the CDISC standards

  • Supported by CDISC XML and HL7 XML transport mechanisms

  • Linked to RIM

2009


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